Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of Blood

5 WARNINGS AND PRECAUTIONS Single-use product. Do not reuse. This product is intended to be single use only and is not intended to be reused or re-sterilized in any manner. Terumo Blood and Cell Technologies cannot ensure the functionality or sterility of the product if it is reused or re-sterilized. Reuse of a single-use disposable set may result in: Product performance issues due to loss of product integrity, including but not limited to the following: Fluid leaks Parts that are warped or deformed Plastics that are brittle and discolored Filters that have reduced filtration capabilities Viral infections such as hepatitis or human immunodeficiency virus (HIV) Bacterial infections Cross-contamination Any of these risks could result in serious injury or death. These risks are shared by product users, donors, patients, and recipients of the end product of the device. Inspect the packaging and the blood bag set prior to use. Do not use the set if any of the following conditions are present: There are tears or holes in the outer aluminum foil packaging or in the individual transparent packaging wrap. The tubing has severe kinks. The blood bag set is incorrectly assembled. The blood bag set is defective or damaged, or there are any leaks from the fluid-filled components of the set. Any clamps are closed. The needle cap is not in place. The solutions are cloudy or discolored or contain particulates. Using the blood bag set under these conditions may result in product contamination or poor performance during collection and/or processing. Note : It is normal to have some condensation in the outer aluminum foil pouch and individual transparent packaging wrap due to sterilization. The blood bag set is no longer sterile if any of the following conditions occur: You disconnect the sample/diversion bag before you seal the sample/diversion tubing. You remove blood samples before you seal the sample/diversion tubing. The integrity of the set is compromised for any reason. Manage the blood bag set according to your institution's SOP. Do not process whole blood less than 2 hours after collection. Processing blood too soon after collection may result in incomplete RBC leukoreduction and/or a reduced platelet yield. Residual leukocytes are a by-product of the processing procedure and contain mostly white blood cells (WBC), with some plasma, platelets, and red blood cells (RBC). Residual leukocytes are not intended for transfusion. Use aseptic technique during blood collection to ensure donor safety and product quality. Do not vent the blood bag set. Do not reuse. ( 5 ) Inspect the packaging and the blood bag set prior to use. ( 5 ) The blood bag set is no longer sterile under certain conditions. ( 5 ) Do not process whole blood less than 2 hours after collection. ( 5 ) Residual leukocytes are not intended for transfusion. ( 5 ) Use aseptic technique during blood collection to ensure donor safety and product quality. ( 5 ) Do not vent the blood bag set. ( 5 )

6. ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 )